Wednesday, February 18, 2004
| Topic: |
The Failure to Disclose Adverse Effects: The Case of the SSRIs |
| Presenter: |
Loren Mosher |
| Location: |
Medical Teaching Facility (MTF) 175 |
Presentation
Abstract
: |
Since the introduction of Lilly's blockbuster drug Prozac in 1987 the Selective Serotonin Reuptake Inhibitors ("SSRI's") have become the standard drug treatment of depression and a variety of putatively related conditions. Prozac and related drugs like Zoloft and Paxil accounted for more than 10 BILLION dollars in sales in the USA in 2001-an 800 % increase since 1990! Soon after Prozac's introduction there was concern that it (and the later SSRI's as well) could cause persons who were never previously suicidal or homicidal to become so. Serious questions have also been raised about their clinical effectiveness and addictive potential.
This is an enormously complicated industry-FDA-institution-investigator-practitioner scientific, ethical, cost, legal and treatment issue.
Each seminar participant will be asked to follow along a timeline that was presented to a jury in a case of a murder/suicide. The survivors claim that Eli Lilly knew its drug Prozac was associated with such adverse events (suicidality and homicidality) before it was brought to market but failed to disclose them. The time line combines Lilly internal documents with citations of relevant articles. |
Discussion
Questions: |
- Do you believe there were ethical violations?
- In such situations what actions should be taken and by whom?
- In this era of "evidence based practice" what effect might "non-disclosure" have on the assessment of "evidence" and determination of risk/ benefit ratios? This discussion should include ethical issues raised by conflicts of interest arising from drug company sponsored consultation, lectureships and investigator and institutional grants.
- Are there ethical concerns about the pharmaceutical industry's RCT designs, suppression of "failed" studies, "owning" the research data and ghost writing of journal articles?
- What does this mean for the process of informed consent?
- What kinds of guidelines should be recommended for the pharmaceutical companies, institutions, the FDA and scientists to minimize ethical violations? How could they be enforced?
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| Readings: |
- Healy, D. (2003) Lines of Evidence on the Risks of Suicide with Selective Serotonin Reuptake Inhibitors. Psychotherapy and Psychosomatics. 72: 71-79. (see also http://www.healyprozac.com)
- Kirsch, I., Moore, T., Scoboria, A. & Nicholls, S. (2002) The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration. Prevention and Treatment. Vol. 5, Article 23, posted July 15, 2002.
http://journals.apa.org/prevention/volume5/pre0050023a.html
- Suicidality and Violence Time-Line (11/12/99): http://www.bhagd.com/media/timeline.html
- Jay Cohen M.D.: MedicationSense.com: Suicides and Homicides in Patients Taking Paxil, Prozac, and Zoloft: Why They Keep Happening - And Why They Will Continue.
http://www.medicationsense.com/articles/oct_dec_03/suicides_homicides.html
- Bola, J. R. (2003). Correspondence: Integrity and bias in academic psychiatry. The British Journal of Psychiatry, 185(5), 464.
http://bjp.rcpsych.org/cgi/content/full/183/5/464?maxtoshow=?eaf
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